A pilot study was conducted to assess the tolerability and the effect on host immunity of a post-surgery adjuvant treatment of melanoma patients with an anti-angiogenic agent, Tamoxifen (TAM, 20 mg/die p.o., daily), combined with immunomodulating cytokines, i.e. recombinant interleukin-2 (IL-2, 4 MUI/m 2 s.c., day 8,10,12) and alpha-2b-interferon (IFN, 3 MUI/m 2 i.m., day 15,17,19), starting a new cycle on day 21, for a total of 12 cycles. Fifty patients (pts) entered into the study, 27 males and 23 females with a median age of 55 years (range 25-75), performance status (ECOG) O with melanoma stage UA (12 patients), stage UB (28 patients), stage III (10 patients). Preliminary in vitro studies showed that TAM does not interfere with up-regulation of natural immunity induced by IFN, IL-2, or IFN + IL-2 in normal peripheral blood mononuclear cells (MNC). The clinical study indicates that the protocol was well tolerated. Increase of NK and LAK activity of patient MNC was observed on day 15. The mean disease-free interval was 10 months and 40 pts were alive at 5 years of follow-up. Further investigations should be performed to test effectiveness of this protocol in a randomized study.

Tricarico M., N.C. (2004). Adjuvant therapy of melanoma patients (Stage II, III): a pilot immuno-toxicological study. JOURNAL OF EXPERIMENTAL & CLINICAL CANCER RESEARCH, 23(4), 573-578.

Adjuvant therapy of melanoma patients (Stage II, III): a pilot immuno-toxicological study

TURRIZIANI, MARIO;BONMASSAR, ENZO;
2004

Abstract

A pilot study was conducted to assess the tolerability and the effect on host immunity of a post-surgery adjuvant treatment of melanoma patients with an anti-angiogenic agent, Tamoxifen (TAM, 20 mg/die p.o., daily), combined with immunomodulating cytokines, i.e. recombinant interleukin-2 (IL-2, 4 MUI/m 2 s.c., day 8,10,12) and alpha-2b-interferon (IFN, 3 MUI/m 2 i.m., day 15,17,19), starting a new cycle on day 21, for a total of 12 cycles. Fifty patients (pts) entered into the study, 27 males and 23 females with a median age of 55 years (range 25-75), performance status (ECOG) O with melanoma stage UA (12 patients), stage UB (28 patients), stage III (10 patients). Preliminary in vitro studies showed that TAM does not interfere with up-regulation of natural immunity induced by IFN, IL-2, or IFN + IL-2 in normal peripheral blood mononuclear cells (MNC). The clinical study indicates that the protocol was well tolerated. Increase of NK and LAK activity of patient MNC was observed on day 15. The mean disease-free interval was 10 months and 40 pts were alive at 5 years of follow-up. Further investigations should be performed to test effectiveness of this protocol in a randomized study.
Pubblicato
Rilevanza internazionale
Articolo
Sì, ma tipo non specificato
Settore MED/06 - Oncologia Medica
ang
Con Impact Factor ISI
angiogenesis inhibitor; antipyretic agent; paracetamol; recombinant alpha2b interferon; recombinant interleukin 2; tamoxifen citrate; adult; aged; article; blood toxicity; cancer adjuvant therapy; cancer staging; chill; clinical article; controlled study; drug efficacy; drug fatality; drug fever; drug tolerability; erythema; female; flu like syndrome; follow up; gastrointestinal toxicity; human; human cell; immune response; immunity; in vitro study; liver toxicity; male; melanoma; mononuclear cell; mucosa inflammation; muscle weakness; myalgia; pilot study; priority journal; treatment outcome; upregulation; Adult; Aged; Cell Line; Chemotherapy, Adjuvant; Disease-Free Survival; Female; Humans; Interferon Alfa-2b; Interferon-alpha; Interferons; Interleukin-2; Killer Cells, Natural; Kinetics; Leukocytes, Mononuclear; Male; Melanoma; Middle Aged; Pilot Projects; Random Allocation; T-Lymphocytes; Tamoxifen; Time Factors; Treatment Outcome; Up-Regulation
Adjuvant therapy; Alpha-Interferon; Interleukin-2; Melanoma; Tamoxifen
http://www.ncbi.nlm.nih.gov/pubmed?term=Adjuvant%20therapy%20of%20melanoma%20patients%20(Stage%20II%2C%20III)%3A%20a%20pilot%20immuno-toxicological%20study
Tricarico M., N.C. (2004). Adjuvant therapy of melanoma patients (Stage II, III): a pilot immuno-toxicological study. JOURNAL OF EXPERIMENTAL & CLINICAL CANCER RESEARCH, 23(4), 573-578.
Tricarico, M; Nunziata, C; Atzori, F; Concolino, F; Macchini, V; D'Atri, S; Prete, Sp; Turriziani, M; Lanzilli, G; Sera, F; Abeni, D; Albanesi, V; Bonmassar, E; Pagani, E
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2108/49147
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